Transcription of DATA SHEET XYNTHA - Medsafe
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data S H E ET XYNTHA moroctocog alfa (rch) (recombinant coagulation factor VIII) NAME OF THE MEDICINE XYNTHA moroctocog alfa (rch) 250, 500, 1000, 2000 IU powder for injection vial. XYNTHA moroctocog alfa (rch) 250, 500, 1000, 2000, 3000 IU powder for injection in a prefilled dual chamber syringe. DESCRIPTION XYNTHA contains moroctocog alfa (rch) (cho), also known as recombinant coagulation factor VIII. Moroctocog alfa rch is a purified protein produced by recombinant DNA technology for use in therapy of factor VIII deficiency (haemophilia A or classic haemophilia). XYNTHA is a purified glycoprotein with an approximate molecular mass of 170 kDa, consisting of 1438 amino acids, which does not contain the non-functional B-domain. The amino acid sequence of moroctocog alfa is comparable to the 90 + 80 kDa form of factor VIII. (The post-translat ional modifications and in vitro functional characteristics of moroctocog alfa are comparable to those of endogenous factor VIII).
solution, containing sodium chloride, sucrose, L-histidine, calcium chloride dihydrate, and polysorbate 80. Each vial/prefilled syringe of XYNTHA contains 1.23 mmol (or 29 mg)
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